Kornimate/medical-research-clean huggingface dataset:
short course primaquine for the radical cure of p. vivax malaria - indonesia

Conditions: Vivax Malaria; G6PD Deficiency

Summary: the proportion of malaria that is the plasmodium vivax species is increasing in indonesia. reducing vivax malaria will require innovative solutions to cure both the blood and liver stages of the disease. this study will evaluate of the feasibility of implementing point-of-care glucose-6-phosphate dehydrogenase deficiency (g6pd) testing. this will be followed by high dose, short course primaquine treatment regimens for patients with vivax malaria, and combined with patient education, surveillance, and pharmacovigilance. we plan to implement the study at 6 health facilities across indonesia using a staged before-and-after study, with a mixed method evaluation.

significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for plasmodium falciparum than p. vivax. p. vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allow it to escape detection and treatment. importantly, they are susceptible only to 8 aminoquinolines such as primaquine however, primaquine is associated with risk of haemolysis in individuals with a genetic condition, called glucose-6-phosphate dehydrogenase (g6pd) deficiency. additionally, the recommended 14-day prolonged treatment regimen is associated with poor treatment adherence hence ineffective primaquine treatment. innovative solutions to the radical cure of both the blood and liver stages of p. vivax are urgently required. the indonesian ministry of health has requested a pragmatic study of the feasibility and cost-effectiveness of implementing point-of-care g6pd testing followed by high-dose, short-course primaquine treatment regimens for patients with vivax malaria. these interventions are to be combined with practicable enhancements to patient education, supervision, malariometric surveillance and pharmacovigilance. this will be a before-after longitudinal health facility-based study implemented at six sites in indonesia; four in papua, one in north sumatra and one in lampung. we will use a staged approach for the implementation of the revised case management strategy, including patient education and counselling,community-based clinical review, with mixed methods evaluation.

Eligibility criteria:
inclusion criteria: * patients with vivax malaria exclusion criteria: * patients who are pregnant * patients who are breastfeeding * patients with a hb \<8g/dl * patients with a previous adverse reaction to primaquine * patient with severe malaria

Keywords: primaquine
pramipexole and bromocriptine on nonmotor symptoms of early parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in parkinson's disease.

primary objective evaluate the improvement of nonmotor symptom scale (nmss) between pramipexole and bromocriptine for early parkinson's disease during 24-week treatment secondary objective * evaluate the improvement for depression which is one of the nonmotor symptoms * evaluate the improvement of clinical symptoms between two groups * evaluate the improvement of quality of life between two groups

Eligibility criteria:
inclusion criteria: * parkinson's disease patients in accordance with uk queensquare brain bank * modified hoehn \& yahr stage \<3 * dopamine agents(levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before. exclusion criteria: * k-mmse\<24 * history of drug-induced parkinsonism * secondary parkinsonism * history of schizophrenia or hallucination * requirement of treatment with anti-depressants due to depressive disorder * pregnant and/or breeding women * renal inadequacy
assessment of executive functions after covid-19

Conditions: Covid19; Cognitive Impairment

Summary: as it is evident that covid-19 may have some impacts on cognition, the primary aim of this study is to investigate -if any- deficits of attention, working memory and executive functions after covid-19.

since covid-19 (coronavirus disease-2019) was declared as a pandemic by the world health organization (who) on december 31, 2019, it is still widespread and deadly. as an ongoing pandemic, it has led to a panic and then a controlled fear in societies. in many studies, neuropsychological deficits were observed in covid-19 patients both during the illness and after recovery. a recent study found that impairment in cognitive functions continued after recovery of covid-19, and it was associated with peripherical inflammatory markers, such as c-reactive protein (crp). crp, as a peripherical inflammatory marker, has been proven to be inversely related to serum levels of the brain-derived neurotrophic factor (bdnf), an important neurotrophin in the growth and differentiation of neurons. in this study, attention, working memory and executive functions of covid-19 patients at post-covid period and its relation with the severity of the disease will be investigated.

Eligibility criteria:
inclusion criteria: covid-19 patients: * diagnosed as covid-19 by rt-pcr at least 60 days but not more than 90 days ago * asymptomatic at the moment * not having any other general medical, neurological or psychiatric conditions except covid-19 at the time of acute infection healthy subjects: * not having any of covid-19 symptoms at the testing time point * not having any general medical, neurological or psychiatric condition exclusion criteria: covid-19 patients: * diagnosed as covid-19 by rt-pcr less than 60 days or more than 90 days ago * having any symptom of acute phase of covid-19 * having any other general medical, neurlogical or psychiatric contidions healthy subjects: * having any of covid-19 symptoms at the testing time point * having any general medical, neurological or psychiatric condition
clinical trial to evaluate the efficacy and safety of d064 and d702 combination therapy

Conditions: Essential Hypertension

Summary: clinical trial to evaluate the efficacy and safety of d064 and d702 combination therapy


Eligibility criteria:
inclusion criteria: * subjects who are 19 years old or older. * subjects who have voluntarily decided to participate in this clinical trial and signed icf. exclusion criteria: 1. subjects with a history of secondary hypertension or suspected secondary hypertension 2. subjects with hypersensitivity or history of clinical trial drugs and similar drugs 3. subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period 4. subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening 5. subjects who received other clinical trial drugs within 4 weeks of screening visit. 6. pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug 7. subjects who are unable to participate in this clinical trial at the discretion of the investigator.
effects of multilac baby on fecal calprotectin levels of colicky babies

Conditions: Infantile Colic

Summary: open trial with two parallel arms, assessing the effects of simethicone and multilac baby on crying behavior and fecal calprotectin levels in babies diagnosed for infantile colic.

babies aged 3 to 6 weeks will be diagnosed for infantile colic using the wessel's criteria. study design will be open label with two parallel arms (simethicone and multilac baby). multilac baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). effects of treatments on crying behavior will be assessed by using parental 24h paper diaries. fecal calprotectin values at the beginning and at the end of the study will be evaluated using bühlmann quantum blue® calprotectin high range (schönenbuch, switzerland), a quantitative immunoassay.

Eligibility criteria:
inclusion criteria: * diagnosed for infantile colic according to wessel's criteria exclusion criteria: * previous treatment with probiotic or synbiotic * previous treatment with antibiotics
adjuvant therapy with neratinib in her2 positive early breast cancer

Conditions: HER2-positive Breast Cancer

Summary: human epidermal growth factor receptor 2 (her2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis. after the appearance of anti-her2 targeted drugs, the prognosis and survival of these patients were greatly improved. in addition to trastuzumab and pertuzumab, the use of tyrosine kinase inhibitor (tki) can further improve the survival. the evidence of previous adjuvant tki anti-her2 therapy was mainly from extenet study. however, due to the limitations of the times, extenet research is based on the background of only trastuzumab targeted therapy. nowadays, there is no evidence that trastuzumab combined patuzumab,use of t-dm1, followed by sequential neratinib can still obtain absolute benefits. therefore, there is no standard for the use of neratinib in current clinical practice. investigators want to explore, in the real world, the efficacy and safety of sequential use of naratinib in adjuvant therapy.

investigators retrospectively recuited patients with early her2 positive breast cancer treated in peking university people's hospital center from january 1, 2019 to november 31, 2024, and prospectively recruit same patients from december 1, 2024 to december 31, 2028. to compare the efficacy and safety of sequential use of neratinib. inclusion criteria: 1. patients with her2 positive breast cancer who were diagnosed by core needle biopsy/operation in peking university people's hospital; 2. the patients were treated in peking university people's hospital and underwent radical resection with hospitalization records; 3. received standard anti-her2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, t-dm1) 4. has signed and agreed to participate in the pkuph breast disease cohort study. exclusion criteria: 1. lack of clinical and pathological data (such as imaging data and pathological data); 2. patients with metastatic breast cancer or bilateral breast cancer; 3. failure to perform radical surgery patients recieved neratinib for 1 year or not. primary end point: 5-year invasive dieased free survival

Eligibility criteria:
inclusion criteria: * 1) patients with her2 positive breast cancer who were diagnosed by core needle biopsy/operation in peking university people's hospital; * 2) the patients were treated in our hospital and underwent radical resection with hospitalization records; * 3) received standard anti-her2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, t-dm1) * 4) has signed and agreed to participate in the pkuph breast disease cohort study. exclusion criteria: * 1) lack of clinical and pathological data (such as imaging data and pathological data); * 2) patients with metastatic breast cancer or bilateral breast cancer; * 3) failure to perform radical surgery

Keywords: adjuvant therapy neratinib
insertion clinical study to evaluate the orientation characteristics of multiple kalifilcon a daily disposable toric ld213001 contact lenses

Conditions: Astigmatism

Summary: the objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon a daily disposable toric lenses as compared to commercially available ultra for astigmatism lenses.


Eligibility criteria:
inclusion criteria: 1. be 18 years or older on the date the informed consent form (icf) is signed and have capacity to read, understand and provide written voluntary informed consent. 2. have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. 3. have no active ocular disease or allergic conjunctivitis. 4. not be using any topical ocular medications. 5. be willing and able to follow instructions. 6. have signed a statement of informed consent. exclusion criteria: 1. participating in a conflicting study. 2. considered by the investigator to not be a suitable candidate for participation.
plus deep water running on low back pain

Conditions: Low Back Pain

Summary: objectives: to evaluate the effect size on non-specific chronic low back pain (clbp) of evidence-based physiotherapy (ebp) with and without the addition of deep water running (dwr) on pain, physical disability and general health state. materials and methods: randomized, double-blind, controlled trial (therapists and assessors) involving 46 persons with clbp over 15 weeks with two interventions, presented three times a week. each group received ebp (personalized exercise program, manual therapy and health education) while one group performed supplementary 20 min sessions of dwr at the individualized aerobic threshold. measurements were made pre and post intervention for pain, disability and general health. range of motion of lumbar spine in the sagittal plane, maximum isometric strength and muscle endurance of lumbar and hip extensors was assessment.


Eligibility criteria:
inclusion criteria: * participants were diagnosed with non-specific clbp, with no radiation to the legs, and lasting at least three months exclusion criteria: * low back pain as a result of specific spinal disease, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or caudal equine syndrome * patients not able to follow instructions * patients with any digressive condition

Keywords: head out water immersion, high intensity exercise, evidence-based physiotherapy; aquatics; hydrotherapy aquatics therapy exercise therapy
biomechanical and viscoelastic properties of thoracolumbar fascia in pregnancy pelvic girdle pain

Conditions: Pregnant Women; Pelvic Girdle Pain

Summary: it has not been objectively clarified how the thoracolumbar fascia (tlf) changes the biomechanical adaptations that occur in the lumbopelvic region during pregnancy and whether it is associated with pelvic girdle pain (pgp). therefore, the aim of this study is to determine the biomechanical and viscoelastic properties of tlf, which adapts to the changes in the lumbopelvic region in pregnant women with pelvic girdle pain, and to investigate its relationship with pgp.


Eligibility criteria:
inclusion criteria: * first-time pregnancy * pregnant women diagnosed with pelvic girdle pain in 1st and 2nd trimesters * pregnant women who do not have pelvic girdle pain in 1st and 2nd trimesters * women not being pregnant * pre-pregnancy body-mass-index (bmi) \< 30 kg/m2 exclusion criteria: * presence of connective tissue disease * deterioration of skin integrity in measurement areas * presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal biomechanical alignment * history of spine, pelvis, or lower extremity surgery or fracture in the past 6 months * definition of chronic low back-pelvic region pain (lasting for more than 3 months and pain severity \>4 according to vas) before pregnancy * identification of metabolic disorders such as type i, ii diabetes, gestational diabetes mellitus (gdm), preeclampsia before and/or during pregnancy)

Keywords: pregnant women pelvic girdle pain thoracolumbar fascia stiffness creep
perioperative administration of tranexamic acid for placenta previa and accreta study

Conditions: Placenta Accreta; Postpartum Hemorrhage; Cesarean Section; Tranexamic Acid

Summary: the purpose of this pilot study is to determine if intravenous tranexamic acid (txa) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. txa is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.

to date, no novel or pharmacologic methods of reducing blood loss have been described for women at risk for placenta accreta. intravenous tranexamic acid (txa), a drug with anti-fibrinolytic activity, is routinely used in elective orthopedic and cardiac surgery to reduce blood loss. intravenous tranexamic acid is currently fda approved for use in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty to reduce peri- and post-operative blood loss and to reduce the need for blood transfusion. there has been growing interest in the application of tranexamic acid in obstetrics and gynecology. in multiple international studies, intravenous txa has been shown to significantly reduce blood loss when given prophylactically with cesarean delivery or vaginal delivery without an increase in morbidity from adverse thrombotic events. txa has not been studied in the particular population of patients requiring cesarean hysterectomy for placenta previa or accreta. this inexpensive, low risk medication has potential to greatly reduce perioperative morbidity and cost when used in a high risk obstetrical population.

Eligibility criteria:
inclusion criteria: * english and spanish speaking pregnant women * any order pregnancy (singleton, twin gestation, etc) * suspected accreta based on ultrasound or mri imaging studies * all women evaluated for placenta accreta and deemed to be high risk for this disease (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal to 2 prior c-sections exclusion criteria: * women less than 18 years of age * women with a personal history of venous or arterial thrombosis (deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke * women with a personal history of a high risk clotting disorder, such as anti-phospholipid syndrome * women who do not have a good understanding of either english or spanish will be excluded. * women with defective color vision (color-blindness)
bone density of large newborn infants and infants of diabetic mothers

Conditions: Bone Density

Summary: bone density was found to be impaired among lage babies and infants of diabetic mothers as found in small group studies. the assumption is that large weight decreases fetal movements and causes decreased bone mineralization.the aim of the study is to compare 2 study groups - of large infants and infants of diabetic mothers to each other and to controls.


Eligibility criteria:
inclusion criteria: * term infants of birth weight 4 kg and above, and * infants of diabetic mothers. exclusion criteria: * preterms, * major congenital malformations, * sick babies.

Keywords: bone density infant of diabetic mother large birth weight
attitudes and understanding of sodium claims on food labels

Conditions: Hypertension

Summary: sodium-related claims on food labels should help people find lower sodium food choices; however consumer attitudes and understanding of such claims are unknown. the objective of this study was to evaluate: 1) the attitudes and understanding to different types of permitted sodium claims and 2) the effect of hypertension on responses to such claims.


Eligibility criteria:
inclusion criteria: * primary grocery shoppers * canadian adults between the ages 20 to 69 years exclusion criteria: * did not have an email address or have access to internet

Keywords: attitudes and understanding of sodium claims general canadian population
paclitaxel and irinotecan in treating patients with advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: this phase ii trial is studying how well giving paclitaxel together with irinotecan works in treating patients with advanced non-small cell lung cancer.

objectives: * determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer. outline: patients receive paclitaxel iv over 1 hour followed immediately by irinotecan iv over 30 minutes. treatment continues weekly for 2 weeks followed by one week of rest. courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 1 year, then every 6 months thereafter. projected accrual: a total of 11-22 patients will be accrued for this study over 12 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic non-small cell lung cancer for which no curative therapy exists * stage iiib with pleural effusion allowed * measurable or evaluable disease * cns metastases allowed if disease stable at least 4 weeks following completion of surgery and/or radiotherapy and no anticonvulsant required patient characteristics: age: * over 18 performance status: * ecog 0-2 life expectancy: * at least 3 months hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * bilirubin less than 2.0 mg/dl * sgot no greater than 3 times upper limit of normal (uln) (no greater than 5 times uln if tumor involves liver) renal: * creatinine clearance at least 70 ml/min other: * no other malignancies within past 3 years except nonmelanomatous skin cancer and carcinoma in situ of the cervix * hiv negative * not pregnant or nursing * negative pregnancy test * fertile patients must use effective birth control * no active infection * no concurrent medical condition that would preclude study participation prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior systemic chemotherapy for lung cancer * no prior irinotecan or paclitaxel endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 4 weeks since prior wide field radiotherapy * no prior radiotherapy to greater than 20% of bone marrow allowed surgery: * see disease characteristics * recovered from prior surgery

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
urinary disorders in patients with multiple sclerosis: invasive vs non-invasive investigations.

Conditions: Multiple Sclerosis; Urinary Bladder, Neurogenic; Urodynamics

Summary: the objective of the study is to describe the current status of ms patients with urinary disorders in lebanon, and to demonstrate whether invasive investigations improve the management of these patients compared to an optimal non-invasive approach.

all patients will be evaluated by an urologist, then randomized into 2 groups, the first group will benefit from non-invasive investigations and will be treated accordingly, the second group will benefit from an urodynamic assessment and will also be treated accordingly. an evaluation will be made one month, 3 months and 6 months after the first visit.

Eligibility criteria:
inclusion criteria: * ms with urinary symptoms exclusion criteria: * bph luts * bladder cancer * prostate cancer * urethral stenosis

Keywords: ms multiple sclerosis urinary bladder, neurogenic urodynamics randomized controlled trial